NCT00463268
Completed
Phase 3
Prevention of Postmenopausal Bone Loss in Osteopenic Women With Alendronate Given on a 70 mg Once-every Two Week Regimen: a 2-year, Double-blind, Placebo-controlled Clinical Trial.
University Hospital of Mont-Godinne1 site in 1 country83 target enrollmentSeptember 2007
Overview
- Phase
- Phase 3
- Intervention
- alendronate
- Conditions
- Osteopenia
- Sponsor
- University Hospital of Mont-Godinne
- Enrollment
- 83
- Locations
- 1
- Primary Endpoint
- percentage of lumbar BMD modification after 2 years
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The purpose of this study is to evaluate the efficacy of the intermittent administration of alendronate in a low dose, 70 mg once every two week, as osteoporosis prevention for menopausal, osteopenic patients, who don't want or can't receive an oestrogenic substitution treatment.
Investigators
Boutsen Yves
professeur
University Hospital of Mont-Godinne
Eligibility Criteria
Inclusion Criteria
- •45 to 60 year-old women
- •Menopausal since at least 6 months
- •Baseline lumbar BMD from -1 till -2.5
Exclusion Criteria
- •Bone disease other than osteopenia
- •Treatment with selective estrogen receptor modulator (SERMs), calcitonin or hormone replacement therapy within 6 monts prior to randomization
- •Former or current treatment with any bisphosphonate or bone forming agents
- •Chronic use of oral or iv corticosteroids
- •Any diagnosis of malignancy less than 12 months
Arms & Interventions
1
Alendronate 70 mg every 2 weeks
Intervention: alendronate
1
Alendronate 70 mg every 2 weeks
Intervention: Calcium/Vitamin D
2
Alendronate 70 mg placebo tablet every 2 weeks
Intervention: Calcium/Vitamin D
2
Alendronate 70 mg placebo tablet every 2 weeks
Intervention: placebo
Outcomes
Primary Outcomes
percentage of lumbar BMD modification after 2 years
Time Frame: 2 years
Secondary Outcomes
- percentage of hip BMD modification (total hip and sub-regions)(2 years)
- percentage of modification of bone remodeling markers(2 years)
Study Sites (1)
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